MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Model Number	2078172
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, non-tortuous left superficial femoral artery.A non-abbott guiding sheath and non-abbott intravascular ultrasound (ivus) catheter were used with a command 14 guide wire.The guide wire and ivus faced resistance during advancement and became stuck together, and the guide wire core became kinked.The devices were removed together, and a new command guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned guide wire and the reported kink was confirmed.The reported difficulty to advance and difficulty to remove were unable to be confirmed due to the returned condition of the guide wire.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.Factors that may contribute to the difficulty to advance or difficulty to remove the guide wire and cause resistance between the devices may include, but not limited to, manufacturing, device placement technique, guiding catheter support, patient anatomical morphology, inner diameter of guide wire lumen or guiding catheter, outer diameter of the guide wire, condition of the guide wire, condition of the guiding catheter, coagulation of blood or procedural contaminates.The investigation was unable to determine a conclusive cause for the reported difficulty to advance/position and difficulty to remove the guide wire through the intravascular ultrasound (ivus) catheter.In this case, it may be possible that during advancement through the anatomy the clearance in the guide wire lumen was reduced resulting in the reported difficulty to advance and remove the command guide wire; however, this could not be confirmed.Manipulation against resistance likely resulted in the reported core kink.The additional noted kinks and bends on the guide wire likely occurred during packing for return analysis.The noted teflon coating damage likely occurred during retraction through the torque device and or other accessory device used in the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI-TORQUE COMMAND 14 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12474853
• Report Number: 2024168-2021-08169
• Device Sequence Number: 11707151
• Product Code: DQX
• UDI-Device Identifier: 08717648176654
• UDI-Public: 08717648176654
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 2078172
• Device Catalogue Number: 2078172
• Device Lot Number: 0071571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EAGLE EYE PLATINUM ST; INTRAVASCULAR ULTRASOUND; PARENT 60 GUIDING SHEATH; EAGLE EYE PLATINUM ST; INTRAVASCULAR ULTRASOUND; PARENT 60 GUIDING SHEATH